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Requirements for different Labeling Levels

image182

Involved In Discussions
#1
For the following three examples:
  1. Gloves do not have individual packaging. 100 gloves are provided per box
  2. Each suture is sealed in a pouch. 10 pouches are provided in a box.
  3. Each graft is sealed in a pouch. 1 pouch is provided in a box.
For example 1 it's sufficient to only place labeling information (e.g. lot number, expiry date, manufacturer name etc...) on the box and not on each individual medical device.

I'm wondering if in example 2 or 3 if it's stated that it's a requirement to place labeling information on the pouch? Is it appropriate to have blank pouches and only have labeling content on the box? Is it perhaps not applicable when there are multiple devices per box but possibly applicable when there is only 1 device per box?

Thanks!
 
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Johnson

Involved In Discussions
#2
For the following three examples:
  1. Gloves do not have individual packaging. 100 gloves are provided per box
  2. Each suture is sealed in a pouch. 10 pouches are provided in a box.
  3. Each graft is sealed in a pouch. 1 pouch is provided in a box.
For example 1 it's sufficient to only place labeling information (e.g. lot number, expiry date, manufacturer name etc...) on the box and not on each individual medical device.

I'm wondering if in example 2 or 3 if it's stated that it's a requirement to place labeling information on the pouch? Is it appropriate to have blank pouches and only have labeling content on the box? Is it perhaps not applicable when there are multiple devices per box but possibly applicable when there is only 1 device per box?

Thanks!
I would suggest that there may be no real diffrence for your 3 example or there is big difference, which will depend on how the goods will be distributed or used, and the importance of the label information and it's identification and traceability etc.

For example, if 100 gloves are always distributed and used in one time with the same purpose, and if the label information is not important for each perpson. I don't see the difference for 3 examples. You just need label one box no matter how they are pacakedor sealed.

But if each glove may be distibuted seperatelly in diffetent time and different group of persons, and if the lable information is important (like the expire date), you need label for each glove no matter how it is packed.
 
D

debbier

#3
Agreed, for all three it depends on how they are used and distributed. If the they are single use and are intended to be stored in the labeled packaged until use, they fall under the general exception for individual single use device under 801.30(a)(3), each unit though would get a virtual unit of use DI.
 
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